IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Manage Pharmacovigilance (PhV) staff responsible for adverse event/ICSR/Clinical Endpoint processing and PhV systems to include project resource assignments, staff hiring, personal development and staff terminations. Responsible for facilitating staff training and professional development. Assist in assuring corporate and departmental quality, financial and productivity
targets are achieved.
• Manage PhV staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Monitor and motivate staff to achieve and maintain acceptable levels of performance.
• Work closely with other department managers to address problem areas, staffing needs, equipment needs, and department resource planning and work scheduling for current and projected projects to ensure deliverables are met.
• Ensure that staff have been trained on and are following Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Working and Project Instructions.
• Leads and encourage direct reports in continuous improvement of department work processes and infrastructure. Instruct and lead direct reports in efficient management of project budgets.
• Monitor with Program Managers and overall Pharmacovigilance management to ensure that department deliverables meet expected quality, financial and productivity targets. Work with Pharmacovigilance management to ensure department realization and utilization targets are met. Ensure department metrics are collected and meet expected targets.
• Assure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, working instructions and client xpectations.
• Assure that, within the functional group assigned, SOPs and Work Instructions are appropriate and current, and that personnel are trained accordingly.
• Facilitate, develop and implement plans for measuring and improving employee engagement
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Extensive knowledge of Pharmacovigilance and safety surveillance
• Excellent staff management skills
• Excellent project management and communication skills
• Excellent motivational coaching and influencing skills
• Excellent leadership skills
• Excellent interpersonal skills
• Excellent team building skills
• Excellent presentation and report writing skills
• Excellent customer focus skills
• High level competence working on multiple tasks and managing competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• For managers of support staff: Bachelor's degree or educational equivalent in health science or other directly related field
and 5 years clinical research experience in a Contract Research Organization or Pharmaceutical company including 2 years management experience; or equivalent combination of education, training and experience
• For managers of medical staff: Bachelor's degree or educational equivalent and 5 years Pharmacovigilance experience including 2 years management experience; or equivalent combination of education, training and experience
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Occasional travel
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1089549